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N/A Completed N=96 Randomized Single-blind Prevention

A Walking Intervention Through Text Messaging

Physical Activity · Behavior · Overweight · Motor Activity
Source: ClinicalTrials.gov NCT02053259 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms. — 9695; 9836; 10562; 8969 steps

Summary

The purpose of this study is to develop and evaluate adaptive goal setting and feedback interventions (Adaptive Interventions) to promote physical activity behaviors and compare it to static physical activity interventions (Static Interventions) using two levels of goal setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All four groups will receive the intervention via a semi-automated text message system developed by the investigators study team. The primary aim of this study will be to: 1. Evaluate whether the adaptive interventions result in greater change in physical activity (pedometer-measured steps/day) compared to the static Intervention groups. HYPOTHESES: Participants in the adaptive interventions will increase their steps/day more than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups. The secondary aims of this study will be to: 2. Evaluate the effectiveness of the adaptive and static goal interventions in improving anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES: Participants in the adaptive interventions will show greater improvements in fitness, lean and fat body mass, and serum biomarkers than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups. 3. to assess participants' satisfaction with the overall program.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Fitbit-measured Steps/Day and Moderate-to-vigorous Physical Activity Between Study Arms.
9695; 9836; 10562; 8969
SECONDARY
Change in Fitness (VO2max) Between Study Arms.
SECONDARY
Changes in Body Mass Index and Body Composition Measured by Dual-energy X-Ray Absorptiometry (DEXA) Between Study Arms.
SECONDARY
Changes to iAortic Pulse Wave Velocity Assessed With the SphymocorTM Between Study Arms.
SECONDARY
Changes to Cardiovascular-disease (CVD) Risk and Inflammatory Markers (e.g. Glucose, Insulin, Lipids, Adhesion Molecules and Hemostatic Factors) Between Groups.
SECONDARY
Changes to Self-reported Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ).

Eligibility Criteria

Inclusion Criteria

  • women and men of all races/ethnicities living in Maricopa County, Arizona.

Exclusion Criteria

  • be between 18 and 60 years old
  • currently not exceeding physical activity recommendations determined by the International Physical Activity Questionnaire (IPAQ short form).
  • not have a medical condition based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) that requires supervised physical activity
  • not taking medication(s) that would prohibit a moderate intensity physical activity program
  • have a body mass index between 25 and 55 kg/m2
  • not be currently pregnant or planning to become pregnant in the next 4 months
  • not be planning to leave Maricopa County for 10 days or more in the next 4 months
  • not planning to move from Maricopa County in the next 4 months
  • not currently in another physical activity, diet, or weight loss program (e.g. weight watchers)
  • have access to Microsoft Windows (XP, Vista, 7, 8) or Mac (10.5+) operating systems on computer with a USB port on a daily basis
  • have daily access to email and the internet
  • have a mobile phone with text messaging capabilities and be willing to send and receive up to 3-5 text messages per day.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02053259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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